pSivida to test BrachySil pancreatic program in European human trial

By Elaine Rigoli

Tampa, Fla., May 30 - pSivida Ltd. announced that the Regulatory Agency in the United Kingdom has granted approval to proceed with the first human study of BrachySil in pancreatic cancer through a phase 2a clinical trial.

The six-month clinical study testing patients with inoperable pancreatic cancer represents the "first-in-man" safety study for BrachySil in this indication and is designed to enroll a total of 15 patients, the company said in a news release.

The primary objective is to determine the safety of the targeted image-guided implantation of BrachySil, the release said.

Efficacy, as determined by CT scanning of the tumor size and overall survival, will be secondary endpoints. The findings will provide a platform for further multi-center efficacy and safety trials.

A phase 2a study for advanced inoperable liver cancer completed in June 2005 on eight patients showed BrachySil to be both safe and well tolerated. All patients experienced a decrease in the size of their tumors, with some experiencing complete tumor regression.

Pancreatic cancer is a second clinical indication for BrachySil, currently in phase 2b clinical trials for the treatment of inoperable primary liver cancer, the release said.

Located in Perth, Australia, pSivida is a bio-nanotech company.

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